Investigating the effect of injectable ketamine with doses of 0.5 mg/kg on the control of symptoms in patients with treatment-resistant major depressive disorder: a randomized clinical trial
Investigating the effect of using a single dose of intravenous ketamine on severe and treatment-resistant depression
Design
Clinical trial without control group, without parallel group, without blinding, without randomization, single phase on 15 patients
Settings and conduct
15 patients were selected according to the inclusion criteria and were given the Hamilton and Beck tests. Then the patients are admitted to Khatam al-Anbia hospital in Shahrood and receive 0.5 mg/kg of ketamine intravenously. This study is without randomization without blinding. Then they are observed for one hour in a stable and quiet room in Khatam Al Anbia Hospital. Then, after two days, one week, one month after the injection, Hamilton and Beck tests are taken from the patients again, and the Hamilton and Beck evaluation test scores are compared before and after the injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with depressive disorder based on DSM IV_TR criteria
Exclusion criteria : Respond to drug therapy or ECT - Cardiovascular problems and pregnancy
Intervention groups
The statistical population includes patients referred to Dr. Hojat Bastami's office who are suffering from treatment-resistant major depressive disorder according to DSM IV_TR criteria and will be injected with 0.5mg/kg of ketamine intravenously as a single dose.
Main outcome variables
Severity of depression
Cognitive complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058520N1
Registration date:2023-07-09, 1402/04/18
Registration timing:registered_while_recruiting
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Mohammad Shiroudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 6920
Email address
dr7sina7sh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-05, 1402/04/14
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of injectable ketamine with doses of 0.5 mg/kg on the control of symptoms in patients with treatment-resistant major depressive disorder: a randomized clinical trial
Public title
Investigating the effect of using ketamine on severe and treatment-resistant depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with treatment-resistant major depressive disorder based on DSM IV _ TR criteria
Being in a depressive episode
Failure to respond to antidepressants and shock medications and failure to control symptoms with other methods
Intolerance of oral antidepressants
Exclusion criteria:
More serious psychiatric disorders: bipolar 1 and 2 - cyclothymia - psychosis - obsession - ski and affective
Addiction or withdrawal from drugs
Personality disorder
Physical diseases such as: thyroid disorders, diabetes, hypertension, stroke, brain surgeries, etc.
Response to drug treatment and control of disease symptoms with drugs
Received ECT two months before starting ketamine treatment
Receiving antidepressant medication one month before starting ketamine treatment
Lack of consent to participate in the study
Cardiovascular problems
Pregnancy and breastfeeding
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood Islamic Azad University
Street address
University Boulevard - Islamic Azad University
City
shahrood
Province
Semnan
Postal code
4318936199
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1401.042
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F33.9
ICD-10 code description
Major depressive disorder, recurrent, unspecified
Primary outcomes
1
Description
Depression score in Beck and Hamilton test.
Timepoint
Comparison of Hamilton and Beck test results before injection, two days after injection, one week after injection, one month after injection
Method of measurement
The criterion of response to ketamine treatment is a decrease of 50% or more in Beck and Hamilton tests.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: receiving 0.5mg/kg ketamine as a single intravenous dose - Rotex medica trittau germany
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Yousef kolookhi
Street address
Khatam Al Anbia Hospital., Opposite Industrial University., University Blvd., Shahrood town
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 2223 7807
Email
khatam@shahrood.ac.ir
Web page address
https://shahrood.iau.ir/khatam-hospital/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Shahrood Islamic Azad University
Full name of responsible person
Sahebali monafi
Street address
Khatam Al Anbia Hospital., Opposite Industrial., University Blvd., University., Shahrood town
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 4279
Email
khatam@shahrood.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Shahrood Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad shiroudi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahrood, Tehran Boulevard, Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 1796
Email
dr7sina7sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yousef kolookhi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahrood, Tehran Boulevard, Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 1796
Email
dr.yousefkolookhi.anesthezia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad shiroudi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahrood, Tehran Boulevard, Shahrood Islamic Azad University
City
Shahrood
Province
Semnan
Postal code
3613773955
Phone
+98 23 3239 1796
Email
dr7sina7sh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available